Merck KGaA submits oral MS drug cladribine to FDA

Germany's Merck KGaA has made further progress in its bid to be the first company to market an oral multiple sclerosis treatment by filing cladribine in the USA.

The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in people with MS. The drug was filed with the European Medicines Agency in July.

The filing is based on the two-year Phase III CLARITY trial, which revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo. Fereydoun Firouz, EMD Serono’s chief executive, said that if approved, short-course therapy with cladribine tablets “could transform the way people approach their treatment options, and meet an unmet need as an oral, disease-modifying drug”.

The company has not given any sales estimates for cladribine but analysts confidently predict blockbuster status for the compound which has been granted fast-track status by the FDA.

News of the filing came hours after Novartis had presented promising initial data from a two-year Phase III trial of its oral MS FTY720 (fingolimod). The Swiss company is planning regulatory submissions in the USA and Europe before the end of the year.